A
| B | C
| D | E
| F | G
| H | I
| J | K
| L | M
N |O
| P | Q
| R | S
| T | U
| V | W
| X | Y | Z
IDE Study
An IDE study is a clinical study that must be reviewed and approved
by the Food & Drug Administration (FDA) to help assure that the
resulting data will be meaningful and that patients will not be exposed
to unreasonable risks. Under the law, the FDA cannot acknowledge the
existence of any study conducted under the IDE unless the manufacturer
publicly announces the existence of the study. Likewise, the FDA cannot
release the results of studies conducted under an IDE unless the manufacturer
has made the data publicly available. Generally, these IDE study data
are used as the basis for a future application to market the device.
In the case of breast implants, women participating in an IDE study
would receive their implants for the uses described in the study protocol/plan.
Each woman who participates in an IDE study must give informed consent,
and an Institutional Review Board (IRB) must oversee the study. An
IRB is composed of scientists, health professionals, and community
members who do not have a bias as to the outcome of the study.
Implant Materials
Implant materials consist a variety of synthetic and non?synthetic
(organic) material that is used to augment or enhance a facial or
body part, such as breast implants, chin implants or other soft tissue
fillers.
Infection
Infection is the state or condition in which the human body is invaded
by a pathogenic agent that can multiply and result in injury.
Informed Consent
Informed consent is the patient's agreement to undergo medical treatment
and correlates to signing of forms that legally allow the surgery
to proceed. Informed consent assumes that the patient has read about,
been educated and understands all of the events, risks and complications
that could take place as a result of surgery.
Institutional Review
Board (IRB)
An IRB is composed of scientists, health professionals, and community
members who oversee and do not have a bias as to the outcome of an
IDE study.
IV Sedation
See Conscious Sedation
A
| B | C
| D | E
| F | G
| H | I
| J | K
| L | M
N |O
| P | Q
| R | S
| T | U
| V | W
| X | Y | Z
